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Blood Test for Early Detection of Breast Cancer Using Todos Medical -Breast 1(TM-B1) Assay (TM-B1)

20. august 2018 opdateret af: Todos Medical, Ltd.
Blood samples from a total of 200 women in two cohorts will be collected and analyzed by TM-B1 assay, which is based on TBIA (Total Biochemical Infrared Analysis) to confirm the presence of cancer. These two cohorts will yield 75 healthy women with no pathological findings, 75 women diagnosed as having benign breast tumor and 50 women diagnosed as having breast cancer.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Prospective, two arms, observational, blinded, cohort study enrolling 200 women which intended to validate the cut-off points between women with malignant tumors, benign tumors, and women without tumors (controls) and to validate the sensitivity and specificity of TM-B1 for the detection of an invasive breast tumor.

Two cohorts will be tested with TM-B1. The cohorts will differ in the percentage of women that are expected to yield a positive finding for breast cancer. Any finding in TM-B1 will not influence medical standards of care.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

200

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Israel
      • Rehovot, Israel, 76100
        • Rekruttering
        • Kaplan Medical Center
        • Kontakt:
        • Ledende efterforsker:
          • Tanir Alweis, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

25 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Cohort 1: Screening Population - Women presenting for routine XRM and / or breast US.

Cohort 2: Breast Cancer Population - Women who were diagnosed with malignant breast tumors, as determined by biopsy, and have not yet begun any treatment for the disease.

Beskrivelse

Inclusion Criteria:

Screening Population:

  • Subject signed the informed consent.
  • Subject is aged 25 years and older.
  • Subject is presenting for routine screening or diagnostic XRM and / or breast US.

Breast Cancer Population

  • Subject signed the informed consent form.
  • Subject is aged 25 years and older.
  • Subject was diagnosed with a malignant breast tumor, and has not yet started treatment.

Exclusion Criteria:

All Subjects:

  • Subject has been diagnosed with any type of malignancy apart from breast cancer.
  • Subject has been previously treated for breast cancer.
  • Subject underwent any surgery within the previous year (apart from benign nevus removal).
  • Subject was treated for benign tumor within the previous year (e.g. polyps or cysts).
  • Subject has an active infection or inflammation from any type of infection (bacterial or viral) as determined clinically at screening.
  • Subject is currently taking medications related directly to, or that can affect, the immune system such as steroids.
  • Subject has any type of active autoimmune disease such as lupus or rheumatoid arthritis.
  • Diagnostic drugs (e.g. contrast materials) were injected or given orally to subject within the last 7 days prior to sample collection for TM-B1 analysis.
  • Subject has been taking any investigational drug which influence her health status within 30 days prior to sample collection for TM-B1 analysis.
  • Subject is not feeling well at the time of blood collection for TM-B1 analysis due to suspected bacterial or viral infection or subject has symptoms such as high fever, diarrhea, headache, vomiting, dizziness etc.
  • Subject is pregnant, lactating, or undergoing fertility treatment.
  • Subject has participated in this study, in another cohort, and the TM-B1 test was performed.

Breast Cancer Population only:

  • The subject's tumor has been surgically removed before sample collection for TM-B1 analysis.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Screening Population

Cohort 1:Screening Population - Women presenting for routine XRM and / or breast US.

Participants will be followed for one year and the outcome of those who undergo an annual XRM / breast ultrasound will be recorded.
Diagnostisk test: Screening Population
Blood samples taken from screening population
Breast Cancer Population
Cohort 2:Breast Cancer Population - Women who were diagnosed with malignant breast tumors, as determined by biopsy, and have not yet begun any treatment for the disease.
Diagnostisk test: Breast Cancer Population
Blood samples taken from Breast Cancer population

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
This study is intended to evaluate the sensitivity and specificity of the TM-B1 test compared to the Gold Standard diagnostic methods and clinical evaluations based on Digital X-Ray Mammography (XRM), and / or ultrasound, and / or MRI and / or pathology.
Tidsramme: Timepoint 1, day 1
the subject's blood (Groups 1 and 2)will be tested for the presence of breast cancer
Timepoint 1, day 1

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
For asymptomatic women who have dense breast tissue (parenchymal density > 50% on XRM), evaluate the performance, in terms of sensitivity and specificity, of the TM-B1 test and XRM together as a breast cancer screening procedure compared to the XRM alone
Tidsramme: Timepoint one, day 1
The subject's blood (Groups 1 and 2) will be tested for the presence of breast cancer
Timepoint one, day 1

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Todos Medical, Ltd.

Efterforskere

  • Ledende efterforsker: Tanir N Alweis, M.D., Kaplan Medical Center,Pasternak St., POB 1, Rehovot 76100, Israel

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

22. januar 2018

Primær færdiggørelse (Forventet)

1. maj 2019

Studieafslutning (Forventet)

1. juli 2019

Datoer for studieregistrering

Først indsendt

12. november 2017

Først indsendt, der opfyldte QC-kriterier

12. november 2017

Først opslået (Faktiske)

17. november 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. august 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. august 2018

Sidst verificeret

1. august 2018

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IL-TM-B1-01

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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